Verified October 10, 2026 against the statutes, regulations and sources cited below. The state decides every application. All states
What testing sites miss in South Dakota
- The CMS-116 and questions go by email to SDCLIA@state.sd.us.
Does South Dakota require a state lab license on top of CLIA?
South Dakota's list of state-licensed health facilities does not include laboratories; the Department of Health notes only that federal law requires labs testing human specimens to be certified. A waived site needs its CLIA Certificate of Waiver.
- Does not reach waived-only labs
Where does a South Dakota CMS-116 go?
- South Dakota Department of Health, Office of Health Care Facilities Licensure and Certification
- Email: SDCLIA@state.sd.us
- Phone: (605) 394-6173
Opening a testing site in South Dakota?
We prepare the CMS-116 and any South Dakota filing for your owner or director to sign, and track both to approval. You pay CMS and the state directly. A Certificate of Waiver application is $399 per site.